Machine Learning Enabled Management of Behavioural and Psychological Symptoms of Dementia Intervention for Dementia Caregivers

Developing and Testing a Machine Learning Enabled Management of Behavioural and Psychological Symptoms of Dementia Intervention for Dementia Caregivers: A Hybrid Experimental Design Study

Develop and test a machine learning enabled management of behavioural and psychological symptoms of dementia intervention for dementia caregivers.

Study Overview

• Status: Not yet recruiting
• Conditions: Dementia Caregiver
• Intervention / Treatment: Behavioral: Active Control; Behavioral: Behavioral: Continue; Behavioral: Behavioral: Enhance human coaching; Behavioral: Behavioral: Booster

• Study Type: Interventional
• Enrollment (Estimated): 550
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Education University of Hong Kong
    • Contact: Kee Lee Chou, PhD; Phone Number: +85229487473; Email: klchou@eduhk.hk
    • Contact: Vivien Tang, MSc; Email: s1135125@s.eduhk.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• aged 18 above
• family caregiver of an individual with a confirmed medical diagnosis of any type of dementia who has been residing in the community
• having been providing care for ADLs and IADLs for at least 20 hours per week for at least one year prior to recruitment
• have a smartphone
• have mild to moderate stress (the 14-item Chinese version Perceived Stress Scale).

Exclusion Criteria:

• having participated in any structured mind-body intervention, cognitive therapy, or structured psychosocial intervention in the 6 months prior to recruitment
• having acute psychiatric and medical comorbidities that are potentially life-threatening (e.g. suicidal ideation) or that limit the caregivers' participation or adherence (e.g. acute psychosis)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

13

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active control	Behavioral: Active Control; No APP based coaching, no human coaching, no rerandomization, no MRT
Experimental: App & Human Coaching + Continue Intervention; First-line of coaching: App + Human Coaching Responder	Behavioral: Behavioral: Continue; Continue with existing intervention plan
Experimental: App & Human Coaching + Increase intensity in human coaching; First-line of coaching: App + Human Coaching Non-Responder	Behavioral: Behavioral: Enhance human coaching; Increase intensity of human coaching
Experimental: App & Human Coaching + Booster; First-line of coaching: App + Human Coaching Non-Responder	Behavioral: Behavioral: Booster; Add a booster session
Experimental: App Coaching + Continue Intervention; First-line of coaching: App Coaching Responder	Behavioral: Behavioral: Continue; Continue with existing intervention plan
Experimental: App Coaching + Increase intensity in human coaching; First-line of coaching: App Coaching Non-Responder	Behavioral: Behavioral: Enhance human coaching; Increase intensity of human coaching
Experimental: App Coaching + Booster; First-line of coaching: App Coaching Non-Responder	Behavioral: Behavioral: Booster; Add a booster session
Experimental: Human Coaching + Continue Intervention; First-line of coaching: Human Coaching Responder	Behavioral: Behavioral: Continue; Continue with existing intervention plan
Experimental: Human Coaching + Increase intensity in human coaching; First-line of coaching: Human Coaching Non-Responder	Behavioral: Behavioral: Enhance human coaching; Increase intensity of human coaching
Experimental: Human Coaching + Booster; First-line of coaching: Human Coaching Non-Responder	Behavioral: Behavioral: Booster; Add a booster session
Experimental: No Coaching + Continue Intervention; First-line of coaching: No Coaching Responder	Behavioral: Behavioral: Continue; Continue with existing intervention plan
Experimental: No Coaching + Increase intensity in human coaching; First-line of coaching: No Coaching Non-Responder	Behavioral: Behavioral: Enhance human coaching; Increase intensity of human coaching
Experimental: No Coaching + Booster; First-line of coaching: No Coaching Non-Responder	Behavioral: Behavioral: Booster; Add a booster session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress	10-item Perceived Stress Scale; each item will be rated from 0=Never to 4=Very often. Total scores range from 0 to 40.	Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Patient Health Questionnaire-9; Each item will be rated from 0=Not at all to 3=nearly everyday. Total scores range from 0 to 27	Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Anxiety	Generalised Anxiety Disorder; each item will be rated from 0=not at all to 3=nearly every day. Total score range from 0 to 21.	Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Physical Health	Lawton Instrumental Activities of Daily Living; each item will be rated 0=dependent to 1=independent. Total scores range from 0 to 8.	Baseline (T0), 32 weeks after baseline assessment (T4)
Physical Health	Activities of Daily Living; each item will be rate from 0=dependent to 5/10=independent. Total scores range from 0 to 100.	Baseline (T0), 32 weeks after baseline assessment (T4)
Physical Symptoms	Wahler Physical Symptoms Inventory; each item will be rated from 0=almost never agree to 5=agree almost every day. Total score range from 0 to 210.	Baseline (T0), 32 weeks after baseline assessment (T4)
Chronic Illness	Participants will indicate any presence of chronic illness (e.g., diabetes, asthma, high blood pressure).	Baseline (T0), 32 weeks after baseline assessment (T4)
Caregiver Burden	12-item Zarit Burden Interview Scale ; each item will be rated from 0=Never to 4=Nearly always. Total scores range from 0 to 48.	Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Psychological Well-Being	18-item Ryff Psychological Well-Being scale, each item range from 1-strongly agree to 7-strongly disagree. Total score range from 18-126.	Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Memory and Behaviour Problems	Revised Memory and Behavior Problems Checklist; a 24-item checklist from 0=never occurred/not at all to 4=daily/extremely. Higher score indicate more frequent behavioral problems/caregiver distress	Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Neuropsychiatric	Neuropsychiatric Inventory Questionnaire; classified each of the 12 domain into presence of symptom, frequency, severity, and caregiver distress.	Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Sleep Quality	Pittsburgh Sleep Quality Index; each item will be rated from 0=No difficulty to 3=Severe difficulty. Total scores range from 0 to 21. Higher scores indicating poorer sleep quality	Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Physical and Mental Health	12-item Short Form Health Survey, Version 2 (SF-12v2). Item responses are aggregated using standard scoring procedures to generate two summary scores: physical and mental. Higher scores indicating better health status	Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiving	Revised Scale for Caregiving Self-efficacy; 15-item scale. Total score is 100.	Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)

Collaborators and Investigators

• Sponsor: Education University of Hong Kong
• Collaborators: The University of Hong Kong; Columbia University; The Hong Kong Polytechnic University; Penn State University; Deakin University; Lingnan University
• Investigators: Principal Investigator: Kee Lee Chou, PhD, The Education University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: machine learning; intervention; dementia caregiver; Hybrid factorial - Sequential Multiple Assignment Randomized Trial, Micro Randomized Trial experimental design
• Other Study ID Numbers: 2023-2024-0387; 22231921 (Other Grant/Funding Number: Research Fund Secretariat, Health Bureau)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No